UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039931 |
|---|---|
| Receipt number | R000044754 |
| Scientific Title | The effect of concentrated video feedback sessions of individual cognitive behavior therapy program in social anxiety disorder |
| Date of disclosure of the study information | 2020/05/01 |
| Last modified on | 2022/09/26 16:40:59 |
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Basic information
Public title
The effect of concentrated video feedback sessions of individual cognitive behavior therapy program in social anxiety disorder
Acronym
The effect of concentrated video feedback sessions of individual cognitive behavior therapy program in social anxiety disorder
Scientific Title
The effect of concentrated video feedback sessions of individual cognitive behavior therapy program in social anxiety disorder
Scientific Title:Acronym
The effect of concentrated video feedback sessions of individual cognitive behavior therapy program in social anxiety disorder
Region
| Japan |
Condition
Condition
Social anxiety disorder
Classification by specialty
| Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare the effects of a counseling-type CBT program, which is conventionally used as psychotherapy, and a CBT program that focuses on cognitive intervention to reduce the burden of video feedback.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese version of Liebowitz Social Anxiety Scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Cognitive behavior therapy: 8 times sessions
1 time video feedback
Interventions/Control_2
Cognitive behavior therapy: 8 times sessions
3 times video feedback
Interventions/Control_3
Questionnaire survey
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Outpatients diagnosed with social anxiety
Key exclusion criteria
High Suicide Risk
Individuals with severe depressive symptoms
Individuals judged difficult by the attending physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Shirotsuki |
Organization
Musashino University
Division name
Faculty of Human Sciences
Zip code
1358181
Address
3-3-3, Ariake, Koto-ku, Tokyo
TEL
0355307624
kenshiro@musashino-u.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Shirotsuki |
Organization
Musashino University
Division name
Faculty of Human Sciences
Zip code
1358181
Address
3-3-3, Ariake, Koto-ku, Tokyo
TEL
0355307624
Homepage URL
kenshiro@musashino-u.ac.jp
Sponsor or person
Institute
Musashino University
Institute
Department
Personal name
Funding Source
Organization
The Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Human Sciences,Musashino University, Research Ethics Committee
Address
3-3-3, Ariake, Koto-ku, Tokyo
Tel
03-5530-7448
masako_k@musashino-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
22
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 25 | Day |
Last modified on
| 2022 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044754
